Tar acids, xylenol fraction

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

fish embryo acute toxicity (FET)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Incubation of fertilized fish eggs in seawater containing test substance. 96-hour EC50 values were determined.

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

100 mL filtered seawater mixed with test substance.

Test organisms (species):

Gadus morrhua

Details on test organisms:

Fertilized eggs were exposed.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Eggs were exposed for 4 days, starting during first day after fertilization. Additionally one experimental series carried out on fish eggs during organogenesis (on days 12-16 after fertilization) and one series on fish larvae from six days after hatching.

Test temperature:

5° C

Nominal and measured concentrations:

control, 0.3, 1.0, 3.0, 10.0 and 30 mg/L (nominal)

Details on test conditions:

- 50 eggs or 20 larvae were placed in test beakers
- Beakers were covered with aluminium foil

Reference substance (positive control):

yes

Remarks:

several other substances

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

3.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: death, pathology, inhibition of cleavage and differentiation, pigment defects

Sublethal observations / clinical signs:

In parallel tests with larvae (6 days after hatching) pigmentation was totally inhibited at 10 and 30 mg/L. Exposure to 3 mg/L gave only poor pigmentation and at 1 mg/L larvae were already paler than the control.

Validity criteria fulfilled:

not applicable

Executive summary:

Effects of 2,4-xylenol to different life stages were measured in a non-guideline study using fertilized fish eggs and larvae of Gadus morrhua. The eggs and larvae were monitored for sublethal effects. An EC50 (96h) of 3.7 mg/L was derived.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

other: US-EPA: Acute Toxicities of Organic Chemicals to Fathead Minnows

GLP compliance:

not specified

Analytical monitoring:

yes

Test organisms (species):

Pimephales promelas

Test type:

flow-through

Total exposure duration:

96 h

Nominal and measured concentrations:

0, 5.2, 8.6, 14.4, 24.0 and 40.0 mg/L

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

16.6 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

EPA OPP 72-1 (Fish Acute Toxicity Test)

GLP compliance:

not specified

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

other: see below

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

 Source: well water, 707.3 mg CaCO3/l

Test temperature:

14 °C

pH:

8.1

Dissolved oxygen:

6.5 mg/l (84.5% of saturation)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.9 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

28.6 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Pimephales promelas

Sublethal observations / clinical signs:

Reliability according to OECD/ICCA HPVC Program 1 (reliable without restrictions)

Reference 4

Endpoint:

fish embryo acute toxicity (FET)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Incubation of fertilized fish eggs in seawater containing test substance. 96-hour EC50 values were determined.

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

100 mL filtered seawater mixed with test substance.

Test organisms (species):

Gadus morrhua

Details on test organisms:

Fertilized eggs were exposed.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Eggs were exposed for 4 days, starting during first day after fertilization. Additionally one experimental series carried out on fish eggs during organogenesis (on days 12-16 after fertilization) and one series on fish larvae from six days after hatching.

Test temperature:

5 °C

Nominal and measured concentrations:

control, 0.3, 1.0, 3.0, 10.0 and 30 mg/L (nominal)

Details on test conditions:

- 50 eggs or 20 larvae were placed in test beakers
- Beakers were covered with aluminium foil

Reference substance (positive control):

yes

Remarks:

several other test substances

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: death, pathology, inhibition of cleavage and differentiation, pigment defects

Sublethal observations / clinical signs:

In parallel tests with larvae (6 days after hatching) pigmentation was totally inhibited at 10 and 30 mg/L. Exposure to 3 mg/L gave only poor pigmentation and at 1 mg/L larvae were already paler than the control.

Validity criteria fulfilled:

not applicable

Executive summary:

Effects of p-cresol to different life stages were measured in a non-guideline study using fertilized fish eggs and larvae of Gadus morrhua. The eggs and larvae were monitored for sublethal effects. An EC50 (96h) of 5 mg/L was derived.

Reference 5

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Method: other

GLP compliance:

no

Analytical monitoring:

yes

Details on test solutions:

5 concentrations in the range of 11.8 to 66.2 mg/l tested (plus control)

Test organisms (species):

Pimephales promelas

Details on test organisms:

28 d old; mean length: 20.9 mm; mean weight: 0.134 g

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Hardness:

Lake Superior water: hardness 47.9 mg CaCO3/l; alkalinity 44.1 mg CaCO3/l;

Test temperature:

24.1 °C

pH:

pH 7.79

Dissolved oxygen:

7.0 mg/l

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

16.5 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

16.5 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

confidence limits (95%):
LC50 = EC50 = 15.9 - 17.0 mg/l
Affected fish lost schooling behaviour and swam near the
tank surface. They were hyperactive and overreactive to
external stimuli. They had increased respiration,
convulsions, and rigid musculature. Some hemorrhaging was
also apparent. They were deformed and lost equilibrium prior
to death.

Reference 6

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Method: static bioassay

GLP compliance:

not specified

Analytical monitoring:

yes

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Test type:

flow-through

Water media type:

freshwater

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.5 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

not specified

Sublethal observations / clinical signs:

No precision qualifier reported

Reference 7

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

static bioassay

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

stock solutions were prepared with 50:50 acetone:water solution

Test organisms (species):

other: see results

Details on test organisms:

TEST ORGANISM
- Length at study initiation (length definition, mean, range and SD): 2- to 9-inch

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

12 °C

Duration:

6 h

Dose descriptor:

LC50

Effect conc.:

4.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

4.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

4.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

6 h

Dose descriptor:

LC50

Effect conc.:

11.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

9.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

8.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

6 h

Dose descriptor:

LC50

Effect conc.:

8.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

6.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

5.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

5.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

13.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Cyprinus carpio

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

15.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Pimephales promelas

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

57.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Ictalurus melas

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

39.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Ictalurus punctatus

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Lepomis macrochirus

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Perca fluviatilis

Reported statistics and error estimates:

The statistical methods of Litchfield and Wilcoxon (1949) were used for determining LC50 values, slope functions, and 95-percent confidence intervals.

Sublethal observations / clinical signs:

Table 1: Test material concentrations (mg/L) in test solutions determined by fluorometric analysis during the experiments (Control = test solution without eggs).

Compound	Control		Cod		Sea urchin
	1 day	4 days	2 days	4 days	2 days	4 days
Phenol	10.27	9.69	10.66	7.67	10.41	10.39
o-cresol	10.17	9.88	10.84	8.45	10.45	9.97
m-cresol	10.44	10.46	10.30	10.06	10.42	10.20
p-cresol	10.30	10.36	11.17	10.59	10.78	10.38
2,3-xylenol	9.48	10.33	10.39	9.08	10.82	9.78
2,4-xylenol	10.11	10.34	10.91	7.27	10.67	9.78
2,5-xylenol	10.37	10.59	10.44	8.68	10.69	10.37
2,6-xylenol	10.34	7.45	10.37	9.09	10.53	9.24
3,4-xylenol	10.37	10.30	10.65	8.32	10.78	10.53
3,5-xylenol	10.48	10.34	10.10	8.56	10.59	9.73

 

Validity criteria fulfilled:

not applicable

Executive summary:

The acute toxicity of p-cresol to fish was determined with a static bioassay on several freshwater species. The highest toxicity is a 96h LC50 value of 4.4 mg/L with Salmo trutta (Howland, 1969).

Reference 8

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

determination of oxygen consumption as a measure for toxic effect

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

other: Lepidocephalichthys guntea (freshwater fish)

Test type:

semi-static

Water media type:

freshwater

Hardness:

80-86 mgL CaCO3

Test temperature:

27-29 °C

pH:

7.0-7.3

Dissolved oxygen:

7.0-7.2 mg/L

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

14 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

not specified

Sublethal observations / clinical signs:

RS-Freetext:
LC50 (24 h) = 21.0 (16.42 - 26.86) mg/l
LC50 (48 h) = 18.0 (14.70 - 22.03) mg/l
LC50 (72 h) = 16.0 (13.20 - 19.39) mg/l
LC50 (96 h) = 14.0 (11.82 - 16.58) mg/l

Reference 9

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Method: other: Test Procedure of the Abwasserabgabengesetzentwurf (Deutscher Bundestag 1974)

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Leuciscus idus

Test type:

static

Water media type:

freshwater

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

11 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC100

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Reference 10

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Principles of method if other than guideline:

Method: other: static bioassay

GLP compliance:

not specified

Analytical monitoring:

no

Test organisms (species):

Gambusia affinis

Test type:

static

Water media type:

freshwater

Limit test:

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

33 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

not specified

Remarks on result:

other: IUCLID4 note: "c" (calculated)

Reference 11

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

US EPA, Methods for acute toxicity tests with fish, macroinvertebrates, and amphibians. Nat. Environm. Res. Center, Corvallis (1974)

GLP compliance:

not specified

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

other: see below

Details on test organisms:

Mean length/mean weight of Onkorhynchus mykiss: 7.9 cm/6.0 g
Mean length/mean weight of Pimephales promelas: 4.9 cm/1.6 g

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

 Source: well water, 707.3 mg CaCO3/l, Conductance: 1212.3 µmhos/cm at 25 degrees C

Test temperature:

14 °C

pH:

8.1

Dissolved oxygen:

6.5 mg/l (84.5% of saturation)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

8.9 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

55.9 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Pimephales promelas

Sublethal observations / clinical signs:

sublethal effects of Oncorhynchus mykiss: hyperactivity, rapid operculation,
sensitive to disturbance; unusual gathering at the surface

sublethal effects of Pimephales promelas: loss of equilibrium, erratic swiming and
twitching at a test substance concentration of 49.8 mg/L

Reliability according to OECD/ICCA HPVC Program 1 (reliable without restrictions)

Reference 12

Endpoint:

fish embryo acute toxicity (FET)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Incubation of fertilized fish eggs in seawater containing test substance. 96-hour EC50 values were determined.

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

100 mL filtered seawater mixed with test substance.

Test organisms (species):

Gadus morrhua

Details on test organisms:

Fertilized eggs were exposed.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Eggs were exposed for 4 days, starting during first day after fertilization. Additionally one experimental series carried out on fish eggs during organogenesis (on days 12-16 after fertilization) and one series on fish larvae from six days after hatching.

Test temperature:

5° C

Nominal and measured concentrations:

control, 0.3, 1.0, 3.0, 10.0 and 30 mg/L (nominal)

Details on test conditions:

- 50 eggs or 20 larvae were placed in test beakers
- Beakers were covered with aluminium foil

Reference substance (positive control):

yes

Remarks:

several other substances

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 30 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: death, pathology, inhibition of cleavage and differentiation, pigment defects

Sublethal observations / clinical signs:

In parallel tests with larvae (6 days after hatching) pigmentation was totally inhibited at 10 and 30 mg/L. Exposure to 3 mg/L gave only poor pigmentation and at 1 mg/L larvae were already paler than the control.

Validity criteria fulfilled:

not applicable

Executive summary:

Effects of m-cresol to different life stages were measured in a non-guideline study using fertilized fish eggs and larvae of Gadus morrhua. The eggs and larvae were monitored for sublethal effects. An EC50 (96h) > 30 mg/L was derived.

Reference 13

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

static bioassay

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

stock solutions were prepared with 50:50 acetone:water solution

Test organisms (species):

other: see results

Details on test organisms:

TEST ORGANISM
- Length at study initiation (length definition, mean, range and SD): 2- to 9-inch

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

12 °C

Duration:

6 h

Dose descriptor:

LC50

Effect conc.:

11 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

8.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

8.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

8.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

6 h

Dose descriptor:

LC50

Effect conc.:

14.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

10.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

10.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

8.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

6 h

Dose descriptor:

LC50

Effect conc.:

11.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

8.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

7.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Reported statistics and error estimates:

The statistical methods of Litchfield and Wilcoxon (1949) were used for determining LC50 values, slope functions, and 95-percent confidence intervals.

Sublethal observations / clinical signs:

Table 1: Test material concentrations (mg/L) in test solutions determined by fluorometric analysis during the experiments (Control = test solution without eggs).

Compound	Control		Cod		Sea urchin
	1 day	4 days	2 days	4 days	2 days	4 days
Phenol	10.27	9.69	10.66	7.67	10.41	10.39
o-cresol	10.17	9.88	10.84	8.45	10.45	9.97
m-cresol	10.44	10.46	10.30	10.06	10.42	10.20
p-cresol	10.30	10.36	11.17	10.59	10.78	10.38
2,3-xylenol	9.48	10.33	10.39	9.08	10.82	9.78
2,4-xylenol	10.11	10.34	10.91	7.27	10.67	9.78
2,5-xylenol	10.37	10.59	10.44	8.68	10.69	10.37
2,6-xylenol	10.34	7.45	10.37	9.09	10.53	9.24
3,4-xylenol	10.37	10.30	10.65	8.32	10.78	10.53
3,5-xylenol	10.48	10.34	10.10	8.56	10.59	9.73

 

Validity criteria fulfilled:

not applicable

Executive summary:

The acute toxicity of m-cresol to fish was determined with a static bioassay on several freshwater species. The highest toxicity is a 96h LC50 value of 7.6 mg/L with Salvelinus fontinalis (Howland, 1969).

Reference 14

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

similar to standard static bioassay

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Pimephales promelas

Test type:

static

Water media type:

freshwater

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

19 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

RS-Freetext:
LC50 (1 h) = 30 mg/l
LC50 (24 h) = 26 mg/l
LC50 (48 h) = 21 mg/l
LC50 (72 h) = 21 mg/l
concentrations are nominal values
endpoint: complete immobilization, equated to death
O2 was =< 4 mg/l during the test

Reference 15

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Method: other: Test Procedure of the Abwasserabgabengesetzentwurf (Deutscher Bundestag 1974)

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Leuciscus idus

Test type:

static

Water media type:

freshwater

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

17 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC100

Effect conc.:

22 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Reference 16

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

static bioassay according to Saarikoski and Viluksela 1981

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Poecilia reticulata

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

96 h

Test temperature:

26 +/- 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

23.12 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Reference 17

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Method: other: Pruefrichtlinie UBA (summer 1980)

GLP compliance:

not specified

Analytical monitoring:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

22 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

15.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

11 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Reference 18

Endpoint:

fish embryo acute toxicity (FET)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Incubation of fertilized fish eggs in seawater containing test substance. 96-hour EC50 values were determined.

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

100 mL filtered seawater mixed with test substance.

Test organisms (species):

Gadus morrhua

Details on test organisms:

Fertilized eggs were exposed.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Eggs were exposed for 4 days, starting during first day after fertilization. Additionally one experimental series carried out on fish eggs during organogenesis (on days 12-16 after fertilization) and one series on fish larvae from six days after hatching.

Test temperature:

5° C

Nominal and measured concentrations:

control, 0.3, 1.0, 3.0, 10.0 and 30 mg/L (nominal)

Details on test conditions:

- 50 eggs or 20 larvae were placed in test beakers
- Beakers were covered with aluminium foil

Reference substance (positive control):

yes

Remarks:

several other substances

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 30 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: death, pathology, inhibition of cleavage and differentiation, pigment defects

Sublethal observations / clinical signs:

In parallel tests with larvae (6 days after hatching) pigmentation was totally inhibited at 10 and 30 mg/L. Exposure to 3 mg/L gave only poor pigmentation and at 1 mg/L larvae were already paler than the control.

Validity criteria fulfilled:

not applicable

Executive summary:

Effects of 3,5-xylenol to different life stages were measured in a non-guideline study using fertilized fish eggs and larvae of Gadus morrhua. The eggs and larvae were monitored for sublethal effects. An EC50 (96h) > 30 mg/L was derived.

Reference 19

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: US-EPA: Acute Toxicities of Organic Chemicals to Fathead Minnows

GLP compliance:

not specified

Analytical monitoring:

yes

Vehicle:

not specified

Test organisms (species):

Pimephales promelas

Test type:

flow-through

Limit test:

no

Total exposure duration:

96 h

Nominal and measured concentrations:

0, 10.5, 16.1, 24.8, 38.2, 58.9

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

10.4 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Reference 20

Endpoint:

fish embryo acute toxicity (FET)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Incubation of fertilized fish eggs in seawater containing test substance. 96-hour EC50 values were determined.

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

100 mL filtered seawater mixed with test substance.

Test organisms (species):

Gadus morrhua

Details on test organisms:

Fertilized eggs were exposed.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Eggs were exposed for 4 days, starting during first day after fertilization. Additionally one experimental series carried out on fish eggs during organogenesis (on days 12-16 after fertilization) and one series on fish larvae from six days after hatching.

Test temperature:

5° C

Nominal and measured concentrations:

control, 0.3, 1.0, 3.0, 10.0 and 30 mg/L (nominal)

Details on test conditions:

- 50 eggs or 20 larvae were placed in test beakers
- Beakers were covered with aluminium foil

Reference substance (positive control):

yes

Remarks:

several other substances

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: death, pathology, inhibition of cleavage and differentiation, pigment defects

Sublethal observations / clinical signs:

In parallel tests with larvae (6 days after hatching) pigmentation was totally inhibited at 10 and 30 mg/L. Exposure to 3 mg/L gave only poor pigmentation and at 1 mg/L larvae were already paler than the control.

Validity criteria fulfilled:

not applicable

Executive summary:

Effects of 2,3-xylenol to different life stages were measured in a non-guideline study using fertilized fish eggs and larvae of Gadus morrhua. The eggs and larvae were monitored for sublethal effects. An EC50 (96h) of 13 mg/L was derived.

Reference 21

Endpoint:

fish embryo acute toxicity (FET)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Incubation of fertilized fish eggs in seawater containing test substance. 96-hour EC50 values were determined.

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

100 mL filtered seawater mixed with test substance.

Test organisms (species):

Gadus morrhua

Details on test organisms:

Fertilized eggs were exposed.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Eggs were exposed for 4 days, starting during first day after fertilization. Additionally one experimental series carried out on fish eggs during organogenesis (on days 12-16 after fertilization) and one series on fish larvae from six days after hatching.

Test temperature:

5° C

Nominal and measured concentrations:

control, 0.3, 1.0, 3.0, 10.0 and 30 mg/L (nominal)

Details on test conditions:

- 50 eggs or 20 larvae were placed in test beakers
- Beakers were covered with aluminium foil

Reference substance (positive control):

yes

Remarks:

several other substances

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: death, pathology, inhibition of cleavage and differentiation, pigment defects

Sublethal observations / clinical signs:

In parallel tests with larvae (6 days after hatching) pigmentation was totally inhibited at 10 and 30 mg/L. Exposure to 3 mg/L gave only poor pigmentation and at 1 mg/L larvae were already paler than the control.

Validity criteria fulfilled:

not applicable

Executive summary:

Effects of 2,6-xylenol to different life stages were measured in a non-guideline study using fertilized fish eggs and larvae of Gadus morrhua. The eggs and larvae were monitored for sublethal effects. An EC50 (96h) of 4 mg/L was derived.

Reference 22

Endpoint:

short-term toxicity to fish

Type of information:

other: secondary source

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Principles of method if other than guideline:

not specifified

GLP compliance:

not specified

Analytical monitoring:

yes

Test organisms (species):

Pimephales promelas

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

8 d

Nominal and measured concentrations:

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 27 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not applicable

Reference 23

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Method: other: Standard methods for the Examination of Water and Wastewater, 12th Ed. Amer. Public Hlth. Assn., Amer. Water Works Assn., and Water Polln. Control Fed., New York (1965)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Lepomis macrochirus

Limit test:

no

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

other: TLm

Effect conc.:

11.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: 100% survival

Sublethal observations / clinical signs:

TLm: median tolerance limit

Interpreted as LC0, since the endpoint is related to 100% survival

Another value, obtained from literature is reported:

TLm = 10.9 mg/l.

Validity criteria fulfilled:

not applicable

Reference 24

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

static bioassay

GLP compliance:

no

Analytical monitoring:

not specified

Vehicle:

no

Test organisms (species):

Ictalurus punctatus

Test type:

static

Water media type:

freshwater

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

15.8 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

11.2 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

4 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

69 h

Dose descriptor:

LC100

Effect conc.:

100 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

69 h

Dose descriptor:

LC50

Effect conc.:

66.8 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

69 h

Dose descriptor:

LC0

Effect conc.:

15.8 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Results are reported as LD (lethal dose).

Validity criteria fulfilled:

not applicable

Reference 25

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

EPA OPP 72-1 (Fish Acute Toxicity Test)

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

concentrations were monitored by HPLC or GC daily during the test

Vehicle:

no

Test organisms (species):

other: see below

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

 Source: well water, 707.3 mg CaCO3/l

Test temperature:

14 °C

pH:

8.1

Dissolved oxygen:

6.5 mg/l (84.5% of saturation)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

8.4 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

18.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Pimephales promelas

Sublethal observations / clinical signs:

Reliability according to OECD/ICCA HPVC Program 1 (reliable without restrictions)

Validity criteria fulfilled:

not specified

Reference 26

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Principles of method if other than guideline:

APHA: Standard Methods for the examination of water and Waste Water (1980)

GLP compliance:

not specified

Test organisms (species):

Sarotherodon mossambicus

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

23.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not applicable

Reference 27

Endpoint:

fish embryo acute toxicity (FET)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Incubation of fertilized fish eggs in seawater containing test substance. 96-hour EC50 values were determined.

GLP compliance:

no

Analytical monitoring:

yes

Details on sampling:

daily

Vehicle:

no

Details on test solutions:

100 mL filtered seawater mixed with test substance.

Test organisms (species):

Gadus morrhua

Details on test organisms:

Fertilized eggs were exposed.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Eggs were exposed for 4 days, starting during first day after fertilization. Additionally one experimental series carried out on fish eggs during organogenesis (on days 12-16 after fertilization) and one series on fish larvae from six days after hatching.

Test temperature:

5 °C

Nominal and measured concentrations:

control, 0.3, 1.0, 3.0, 10.0 and 30 mg/L (nominal)

Details on test conditions:

- 50 eggs or 20 larvae were placed in test beakers
- Beakers were covered with aluminium foil

Reference substance (positive control):

yes

Remarks:

several other test substances

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

12 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: death, pathology, inhibition of cleavage and differentiation, pigment defects

Sublethal observations / clinical signs:

In parallel tests with larvae (6 days after hatching) pigmentation was totally inhibited at 10 and 30 mg/L. Exposure to 3 mg/L gave only poor pigmentation and at 1 mg/L larvae were already paler than the control.

Validity criteria fulfilled:

not applicable

Executive summary:

Effects of o-cresol to different life stages were measured in a non-guideline study using fertilized fish eggs and larvae of Gadus morrhua. The eggs and larvae were monitored for sublethal effects. An EC50 (96h) of 12 mg/L was derived.

Reference 28

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: US-EPA: Acute Toxicities of Organic Chemicals to Fathead Minnows

Principles of method if other than guideline:

Method: bioassay test

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

NaOH was used to increase the solubility of the test substance. The pH of the stock solution was then adjusted to that of lake water.
5 concentrations in the range of 8.26 to 46.4 mg/l tested (plus control)

Test organisms (species):

Pimephales promelas

Details on test organisms:

29 d old; mean length: 17.9 mm; mean weight: 0.083 g

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Lake Superior water: hardness 46.8 mg CaCO3/l; alkalinity 44.4 mg CaCO3/l;

Test temperature:

24.6 °C

pH:

pH 7.7

Dissolved oxygen:

6.9 mg/l

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

14 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

14 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

behaviour

Sublethal observations / clinical signs:

confidence limits (95%):
LC50 = EC50 = 13.2 - 14.8 mg/l
Affected fish lost schooling behaviour and swam near the
tank surface. They were hyperactive and overreactive to
external stimuli. They had increased respiration. They were also darkly colored. Equilibrium loss was not observed prior death.

Reference 29

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

static bioassay

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

stock solutions were prepared with 50:50 acetone:water solution

Test organisms (species):

other: see results

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

12 °C

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

7.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

7.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

6.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salmo trutta

Duration:

6 h

Dose descriptor:

LC50

Effect conc.:

11 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

9.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

8.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Oncorhynchus mykiss

Duration:

6 h

Dose descriptor:

LC50

Effect conc.:

14.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

7.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

7.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Salvelinus fontinalis

Reported statistics and error estimates:

The statistical methods of Litchfield and Wilcoxon (1949) were used for determining LC50 values, slope functions, and 95-percent confidence intervals.

Sublethal observations / clinical signs:

Table 1: Test material concentrations (mg/L) in test solutions determined by fluorometric analysis during the experiments (Control = test solution without eggs).

Compound	Control		Cod		Sea urchin
	1 day	4 days	2 days	4 days	2 days	4 days
Phenol	10.27	9.69	10.66	7.67	10.41	10.39
o-cresol	10.17	9.88	10.84	8.45	10.45	9.97
m-cresol	10.44	10.46	10.30	10.06	10.42	10.20
p-cresol	10.30	10.36	11.17	10.59	10.78	10.38
2,3-xylenol	9.48	10.33	10.39	9.08	10.82	9.78
2,4-xylenol	10.11	10.34	10.91	7.27	10.67	9.78
2,5-xylenol	10.37	10.59	10.44	8.68	10.69	10.37
2,6-xylenol	10.34	7.45	10.37	9.09	10.53	9.24
3,4-xylenol	10.37	10.30	10.65	8.32	10.78	10.53
3,5-xylenol	10.48	10.34	10.10	8.56	10.59	9.73

 

Validity criteria fulfilled:

not applicable

Executive summary:

The acute toxicity of o-cresol to fish was determined with a static bioassay on several freshwater species. The highest toxicity is a 96h LC50 value of 6.2 mg/L with Salmo trutta (Howland, 1969).

Reference 30

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Method: other: Standard Methods for the Examination of Water and
Wastewater, 11th Ed., Amer. Pub. Health Assn., New York
(1960)

GLP compliance:

no

Analytical monitoring:

not specified

Test organisms (species):

other: see below

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

12.55 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Pimephales promelas

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

20.78 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Lepomis macrochirus

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

23.25 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Carassius auratus

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

18.85 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Lebistes reticulata

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

13.42 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: in hard water; Pimephales promelas

Sublethal observations / clinical signs:

Results are reported as TLM (median tolerance limits).

Validity criteria fulfilled:

not applicable

Reference 31

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Method: other: Test Procedure of the Abwasserabgabengesetzentwurf (Deutscher Bundestag 1974)

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Leuciscus idus

Test type:

static

Water media type:

freshwater

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

14 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC100

Effect conc.:

20 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not applicable

Reference 32

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

static bioassay

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

not specified

Test organisms (species):

other: see below

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: tap water; Oncorhynchus mykiss

Duration:

48 h

Dose descriptor:

other: NOLC Oncorhynchus mykiss

Effect conc.:

3.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

41 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Dutch standard water; Oryzias latipes

Duration:

48 h

Dose descriptor:

other: NOLC: Oryzias latipes

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

34 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Dutch standard water; Pimephales promelas

Duration:

48 h

Dose descriptor:

other: NOLC: Pimephales promelas

Effect conc.:

30 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Further results, obtained from literature are reported:

Leuciscus idus: 48 -LC50 = 18 mg/l

Poecilia reticulata: 48h-LC50 = 38 mg/l (48h-NOLC = 27 mg/l)

Reference 33

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

other: DIN 38412

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

no

Test organisms (species):

other: see below

Test type:

static

Water media type:

freshwater

Limit test:

no

pH:

7.5 +/-0.3

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

20 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Danio rerio

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

24 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Danio rerio

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

30 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Danio rerio

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

10 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ; Leuciscus idus

Reference 34

Endpoint:

fish embryo acute toxicity (FET)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Incubation of fertilized fish eggs in seawater containing test substance. 96-hour EC50 values were determined.

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

100 mL filtered seawater mixed with test substance.

Test organisms (species):

Gadus morrhua

Details on test organisms:

Fertilized eggs were exposed.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Eggs were exposed for 4 days, starting during first day after fertilization. Additionally one experimental series carried out on fish eggs during organogenesis (on days 12-16 after fertilization) and one series on fish larvae from six days after hatching.

Test temperature:

5° C

Nominal and measured concentrations:

control, 0.3, 1.0, 3.0, 10.0 and 30 mg/L (nominal)

Details on test conditions:

- 50 eggs or 20 larvae were placed in test beakers
- Beakers were covered with aluminium foil

Reference substance (positive control):

yes

Remarks:

several other substances

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: death, pathology, inhibition of cleavage and differentiation, pigment defects

Sublethal observations / clinical signs:

In parallel tests with larvae (6 days after hatching) pigmentation was totally inhibited at 10 and 30 mg/L. Exposure to 3 mg/L gave only poor pigmentation and at 1 mg/L larvae were already paler than the control.

Validity criteria fulfilled:

not applicable

Executive summary:

Effects of 3,4-xylenol to different life stages were measured in a non-guideline study using fertilized fish eggs and larvae of Gadus morrhua. The eggs and larvae were monitored for sublethal effects. An EC50 (96h) of 13 mg/L was derived.

Reference 35

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

no guideline required

Principles of method if other than guideline:

Data from handbook.

GLP compliance:

not specified

Analytical monitoring:

not specified

Test organisms (species):

Pimephales promelas

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

14 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not applicable

Reference 36

Endpoint:

fish embryo acute toxicity (FET)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Incubation of fertilized fish eggs in seawater containing test substance. 96-hour EC50 values were determined.

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

100 mL filtered seawater mixed with test substance.

Test organisms (species):

Gadus morrhua

Details on test organisms:

Fertilized eggs were exposed.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Eggs were exposed for 4 days, starting during first day after fertilization. Additionally one experimental series carried out on fish eggs during organogenesis (on days 12-16 after fertilization) and one series on fish larvae from six days after hatching.

Test temperature:

5° C

Nominal and measured concentrations:

control, 0.3, 1.0, 3.0, 10.0 and 30 mg/L (nominal)

Details on test conditions:

- 50 eggs or 20 larvae were placed in test beakers
- Beakers were covered with aluminium foil

Reference substance (positive control):

yes

Remarks:

several other substances

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: death, pathology, inhibition of cleavage and differentiation, pigment defects

Sublethal observations / clinical signs:

In parallel tests with larvae (6 days after hatching) pigmentation was totally inhibited at 10 and 30 mg/L. Exposure to 3 mg/L gave only poor pigmentation and at 1 mg/L larvae were already paler than the control.

Validity criteria fulfilled:

not applicable

Executive summary:

Effects of 2,5-xylenol to different life stages were measured in a non-guideline study using fertilized fish eggs and larvae of Gadus morrhua. The eggs and larvae were monitored for sublethal effects. An EC50 (96h) of 13 mg/L was derived.

Reference 37

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

14 - 26 Mar 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted July 17, 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

May 30, 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Analytical monitoring:

yes

Details on sampling:

- Concentrations: All test concentrations and the control.
- Sampling method: Duplicate samples were taken at the start of from the freshly prepared test media. At test end duplicate samples were collected at the end of the test (after 96 h) from the approximate centre of the aquaria. The samples of 10 mg test item/L were already taken after 24 h because all fish were dead.
- Sample storage conditions before analysis: The samples from test start were stored in a refrigerator (4 °C), protected from light until analysis was performed.
- Others: From the test start samples the samples of the concentration of 5 mg test item/l and one of the samples of 2.5 mg test item/L were not analysed because of damage.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution of 300 mg test item/L was prepared by dissolving 320.8 mg test item into 1069.33 mL test water by intense stirring for 10 min. Adequate volumes of this stock solution were diluted with test water to prepare the test media of the desired test concentrations.
- Controls: In the control, test water was used without addition of the test item.
- Evidence of undissolved material: The test media were clear and colourless.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Forellenzuchtbetrieb Störk, 88348 Bad Saulgau, Germany
- Age at study initiation (mean and range, SD): Juveniles
- Length at study initiation: 5.28 cm ± 0.2 cm
- Weight at study initiation: 1.48 g ± 0.2 g

ACCLIMATION
- Acclimation period: least 12 days
- Acclimation conditions: They were held in water of the quality to be used in the test for at least seven days immediately before testing under the following conditions: 16 hours photoperiod daily, 13 - 17 °C, at least 80% of the air saturation value,
- Feeding frequency during acclimation: Three times per week or daily until 24 h before the test was started.
- Health during acclimation (any mortality observed): During the last 7 days prior to the start of the test no fish (0%) died.

FEEDING DURING TEST : no feeding during the test
- Frequency: Three times per week or daily until 24 hours before the test was started

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

2.5 mmol/L (= 250.0 mg/L) as CaCO3

Test temperature:

13.5 - 13.7 (Control)
13.4 - 13.9 (Test Item concentrations)

pH:

7.6 - 7.8 (Control)
7.6 - 7.8 (Test Item concentrations)

Dissolved oxygen:

97 - 100% (Control)
95 - 100% (Test Item concentrations)

Nominal and measured concentrations:

0.63, 1.25, 2.5, 5.0 and 10 mg/L (nominal)

Details on test conditions:

TEST SYSTEM
Test vessel:
- Type: open
- Material, size, headspace, fill volume: 16 litre glass aquaria with 12 litre test medium
- Aeration: The test media were slightly aerated during the test.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.865 g fish/L test water

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: In deionised water (conductivity ≤ 10 µScm-1) analytical grade salts were added.
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4:1 (based on molarity)
- Na/K ratio: 10:1 (based on molarity)
- Culture medium different from test medium: No
- Intervals of water quality measurement: The water temperature, pH-values and the dissolved oxygen concentrations were determined daily in the test media of each treatment group.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light : 8 h dark; 30 min dawn/dusk period was provided
- Light intensity: 510 to 660 lux

EFFECT PARAMETERS MEASURED: The test fish were observed at test start and after approximately 2, 24, 48, 72 and 96 h test duration for sublethal effects and mortality. Dead fish were removed at least once daily and discarded.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: Yes, a non-GLP test was performed

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.07 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Biological observations: At the concentrations up to 5.0 mg test item/L, all fish survived until the end of the experiment and no signs of intoxication occurred. At 10.0 mg test item/L, all fish were dead after 24 hours.
- Mortality of control: In the control all fish survived until the end of the experiment and no signs of intoxication occurred.

Reported statistics and error estimates:

The LC50 was calculated as the geometric mean of the lowest concentration causing no mortality (5.0 mg test item/L) and the lowest concentration resulting in 100 % mortality (10.0 mg test item/L). The NOEC, the LOEC, the LC0 and the LC100 were determined directly from the raw data.
The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat® Solutions GmbH.

Sublethal observations / clinical signs:

Biological Results:

Table 1: Observed Mortality

Nominal Concentration	Mortality
mg test item/L	0 h	2 h	24 h	48 h	72 h	96 h
	# mort	# mort	# mort	# mort	# mort	# mort
Control	0	0	0	0	0	0
0.63	0	0	0	0	0	0
1.25	0	0	0	0	0	0
2.5	0	0	0	0	0	0
5.0	0	0	0	0	0	0
10	0	0	7	7	7	7
LC50 [mg test item/L]	n.d.	n.d.	7.07	7.07	7.07	7.07
95 % CI mg test item/L]	n.d.	n.d.	5.0 - 10.0	5.0 - 10.0	5.0 - 10.0	5.0 - 10.0

# mort:Cumulative number of dead fish; n.d.: not determinable; CI.: Confidence intervalValues refer to nominal test concentrations.

Table 2: Cumulative mortality and Sublethal Effects

Mortality and Sublethal Effects Nominal Concentrations [mg test item/L]
Time		Control	0.63	1.25	2.5	5.0	10
0 h	#mort	0	0	0	0	0	0
	#symp	0	0	0	0	0	0
	symp	-	-	-	-	-	-
2 h	#mort	0	0	0	0	0	0
	#symp	0	0	0	0	0	7
	symp	-	-	-	-	-	TS,DC,DA
24 h	#mort	0	0	0	0	0	7
	#symp	0	0	0	0	0	0
	symp	-	-	-	-	-	-
48 h	#mort	0	0	0	0	0	7
	#symp	0	0	0	0	0	0
	symp	-	-	-	-	-	-
72 h	#mort	0	0	0	0	0	7
	#symp	0	0	0	0	0	0
	symp	-	-	-	-	-	-
96 h	#mort	0	0	0	0	0	7
	#symp	0	0	0	0	0	0
	symp	-	-	-	-	-	-

# mort:Cumulative number of dead fish            

# symp:              Number of fish with sublethal effects  

DA: distended abdomen           

DC: dark colouration     

TS: tumbling during swimming 

Analytical Results:

The quantification of the carbon content of the test item Tar acid xylenol fraction, 2,4/2,5 rich in the test samples was performed by analysing the Total Organic Carbon content (TOC). The loading rates of the carbon content of the test item were determined in the duplicate test media samples from test loading rates 0.63, 1.25 and 10 mg test item/L and the duplicate control samples from all sampling times. One of the duplicate samples of test start and the duplicate samples of test end of the concentration of 2.5 mg test item/L as well as the duplicate samples of the aged test media of the samples of 5 mg test item/L were analysed. The mean measured values of the quantifiable samples are 8.16 mg Carbon/L in the samples of 10 mg test item/L , 4.02 mg test item/L in the samples of 5.0 mg test item/L, 1.89 mg test item/L in the samples of 2.5 mg test item/L and 1.13 mg test item/L in the samples of 1.25 mg test item/L.

Table 3: Summary of Analytical Results

Sample Description	Total Organic Carbon
nominal concentration	TOC	RSD
[mg test item/L]	[mg Carbon/L]^1	[%]	n
Control	n.a.	n.a.	4
0.63	<LOQ	n.a.	4
1.25	1.13	9	4
2.5	1.89	5	3
5.0	4.02	1	2
10	8.16	2	4

¹mean value of all measured samples per treatment group

RSD: relative standard deviation per treatment group

n: number of analysed samples

n.a.: not applicable

Table 4: Validity criteria

Criterion from the guideline	Outcome	Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test	0%	Yes
The dissolved oxygen concentration must have been at least 60 per cent of the air saturation value throughout the test	Did not fall below 95%	Yes

Validity criteria fulfilled:

yes

Remarks:

For further details please refer to “Any other information on results incl. tables”.

Reference 38

Endpoint:

short-term toxicity to fish

Type of information:

other: secondary source

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Principles of method if other than guideline:

not specifified

GLP compliance:

not specified

Analytical monitoring:

not specified

Test organisms (species):

Carassius auratus

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Nominal and measured concentrations:

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

22 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: effect value originally reproted as TLm

Validity criteria fulfilled:

not applicable

Reference 39

Endpoint:

short-term toxicity to fish

Type of information:

other: secondayr source

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Principles of method if other than guideline:

not specifified

GLP compliance:

not specified

Analytical monitoring:

not specified

Test organisms (species):

Pseudopleuronectes americanus

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Nominal and measured concentrations:

control, 3.75, 7.5, 15, 30, and 60 mg/L (nominal)

Details on test conditions:

- unaerated
- survival measured at four periods during the exposure period from 24 to 96 hours post treatment

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

12 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not applicable

Description of key information

Based on all available information (weight-of-evidence) and following a worst case approach the 96h freshwater LC50 of 4.4 mg/L determined for Salmo trutta (Howland, 1969) for p-cresol and the 96h saltwater EC50 of 3.7 mg/L determined with eggs of Gadus morrhua (Falk-Petersen et al., 1985) for 2,4-xylenol represent the most sensitive effect values for acute toxicity to fish for constituents of Tar acids, Xylenol fraction (CAS 84989-06-0) and are considered key values for the chemical safety assessment. This values are slightly lower than the LC50 96h of 7.07 mg/L (nominal) determined for the UVCB mixture Tar acids, Xylenol fraction (CAS 84989-06-0) as a whole (Lührs & Scheider, 2019).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

4.4 mg/L

Marine water fish

Marine water fish

Effect concentration:

3.7 mg/L

Additional information

One experimental study is available investigating the short-term toxicity of Tar acids, Xylenol fraction (CAS 84989-06-0) to freshwater fish (Lührs & Schneider, 2019). The study was performed under static conditions according to OECD guideline 203 and GLP. Rainbow trout Oncorhynchus mykiss was exposed to nominal test item concentrations of 0.63, 1.25, 2.5, 5.0 and 10 mg/L. The exposure concentrations during the test were verified by total organic carbon measurements. The analysed concentrations of the carbon content of the test item were within ± 20% of the measured initial concentrations during the test. In the control and at the concentrations up to 5.0 mg test item/L, all fish survived until the end of the experiment and no signs of intoxication occurred. At 10.0 mg test item/L, all fish were dead after 24 hours. The LC50 (96h) was determined to be 7.07 mg/L (geometric mean of the lowest concentration causing no mortality (5.0 mg test item/L) and the lowest concentration resulting in 100 % mortality (10 mg test item/L)).

Numerous further data on the acute toxicity to fish are available for constituents of Tar acids, Xylenol fraction (CAS 84989-06-0). The determined effect values (LC50, 96h) for acute toxicity to fish ranges between 3.7 mg/L and 33 mg/L. As a worst case approach the lowest effect values of the constituents were considered key values for the chemical safety assessment by applying a weight of evidence and an analogue read-across approach. The most sensitive value for freshwater was determined for Salmo trutta with an LC50 (96h) of 4.4 mg/L for p-cresol (Howland, 1969). For saltwater the most sensitive effect value is an EC50 (96h) of 3.7 mg/L determined for 2,4-xylenol in a fish egg test with Gadus morrhua (Falk-Petersen et al., 1985). These values are considered for PNEC derivation and risk assessment and for deriving environmental classification. For details on the read-across approach please refer to the analogue justification provided in IUCLID section 13.

Acute effect value determined for Tar acids, Xylenol fraction:

Source	*	Species
Lührs & Scheider, 2019	f	Oncorhynchus mykiss	LC50 (96h) = 7.07 mg/L

Acute effect values determined in the numerous studies available on constituents of Tar acids, Xylenol fraction:

Source	*	Species	p-cresol	m-cresol	o-cresol
Howland, 1969	f	various species	LC50 (96h) = 4.4 mg/L	LC50 (96h) = 7.6 mg/L	LC50 (96h) = 6.2 mg/L
DeGraeve et al., 1980	f	various species	LC50 (96h) = 7.9 mg/L	LC50 (96h) = 8.9 mg/L	LC50 (96h) = 8.4 mg/L
Saarikorski & Viluksela, 1982	f	Poecilia reticulataoecilia reticulata	-	LC50 (96h) = 23.12 mg/L	-
Wellens, 1982	f	Danio rerio	-	LC50 (96h) = 15.9 mg/L	LC50 (96h) = 24 mg/L
Ruebelt et al., 1982	f	Leuciscus idus	LC50 (48h) = 11 mg/L	LC50 (48h) = 17 mg/L	LC50 (48h) = 14 mg/L
Hodson et al., 1984	f	Oncorhynchus mykiss	LC50 (96h) = 7.5 mg/L	-	-
Kanabur & Sangli, 1998	f	Lepidocephalichthys guntea	LC50 (96h) = 14 mg/L	-	-
Mattson et al., 1976	f	Pimephales promelas	LC50 (96h) = 19 mg/L	-	-
Sangli & Kanabur, 2000	f	Gambusia affinis	LC50 (96h) = 33 mg/L	-	-
Geiger et al., 1986	f	Pimephales promelas	LC50 (96h) = 16.5 mg/L	-	LC50 (96h) = 14 mg/L
Buzzel et al., 1968	f	Lepomis macrochirus	-	-	TLM (96h) > 11.5 mg/L
Devi & Sastri, 1987	f	Sarotherodon mossambicus	-	-	LC50 (96h) = 23.5 mg/L
Slooff et al., 1982-1983	f	various species	-	-	LC50 (48h) = 13 mg/L
Pickering & Henderson, 1966	f	various species	-	-	LC50 (96h) = 12.55 mg/L
Clemens & Sneed, 1959	f	Ictalurus punctatus	-	-	LC50 (96h) = 11.2 mg/L
Falk-Petersen et al., 1985	m	Gadus morrhua (eggs)	EC50 (96h) = 5 mg/L	EC50 (96h) > 30 mg/L	EC50 (96h) = 12 mg/L
			2,3-xylenol	2,4-xylenol	2,5-xylenol
Geiger et al., 1985	f	Pimephales promelas	-	LC50 (96h) = 16.6 mg/L	-
Falk-Petersen et al., 1985	m	Gadus morrhua (eggs)	EC50 (96h) = 13 mg/L	EC50 (96h) = 3.7 mg/L	EC50 (96h) = 13 mg/L
			2,6-xylenol	3,4-xylenol	3,5-xylenol
SIDS, 2010	f	Pimephales promelas	LC50 (96h) > 27 mg/L	-	-
SIDS, 2010	f	Carassius auratus	-	-	LC50 (96h) = 22 mg/L
SIDS, 2010	m	Pseudopleuronectes americanus	LC50 (96h) = 12 mg/L	-	-
Verschueren, 1983	f	Pimephales promelas	-	LC50 (96h) = 14 mg/L	-
Falk-Petersen et al., 1985	m	Gadus morrhua (eggs)	EC50 (96h) = 4 mg/L	EC50 (96h) = 13 mg/L	EC50 (96h) > 30 mg/L
			4-ethylphenol
Geiger et al., 1986	f	Pimephales promelas	LC50 (96h) = 10.4 mg/L	-	-

* f = freshwater, m = marine